The following is a transcription of the above video, and The Market Herald Canada has edited it for clarity.
Theralase Technologies Inc. (TSXV:TLT), a clinical-stage pharmaceutical company, is currently developing an innovative, research-backed technology for the treatment of bladder cancer.
I sat down with President, CEO and founder Roger DuMoulin-White, who spoke about the fascinating work that the company is doing.
TMH: For our listeners who may not be aware, can you provide some background about your company?
DuMoulin-White: Theralase first started as a medical device company 30 years ago. At that point, we researched and developed medical lasers to treat pain conditions. The technology worked extremely well. We still operate that division today.
About 20 years ago, the company pivoted into cancer research as we became interested in specially designed molecules that had the ability to localize to cancer cells versus healthy cells and then when light activated, destroy the cancer cells leaving the healthy cells unharmed.
We’ve researched and developed these light sensitive molecules over the last 20 years, and we’ve now advanced to the clinical research stage where we are enrolling and providing the treatment to bladder cancer patients very successfully. When completed and if successful, Theralase hopes to commercialize this revolutionary technology for the benefit of all bladder cancer patients.
TMH: Tell me more about this clinical study; specifically, how does it work and what have been the results.
DuMoulin-White: It’s very interesting. The clinical study has been designed as an FDA and a Health Canada registration study, meaning that if it meets its design endpoints, pending regulatory approval of course, it can be commercialized. The technology works by instilling the drug into the patient’s bladder and allowing it to be absorbed by the cancer cells.
After it’s been absorbed, the patient’s brought to the operating room, placed under general, and then the drug is light activated so the patient can be treated in the morning and go home in the afternoon and hopefully cancer-free.
To date the company and the hospitals that provide the treatment have treated 63 patients demonstrating a destruction of their bladder cancer in two-thirds of those cases and a duration of that response in one-third of those patients. So quite remarkable.
Theralase technology is superior, both in efficacy and safety to all current FDA approved drugs.
TMH: Moving over to the recent non-brokered, private placement that Theralase closed. Can you walk us through this deal and what it means for the company?
DuMoulin-White: Absolutely. It was a small private placement, so it was $1.17 million. We closed it at the end of November 2023, and we’re using it as a stepping stone for the company into 2024 where the company plans to start negotiating other forms of financing, specifically distribution agreements, partnering agreements, royalty agreements, equity or debt agreements, or all of the above, all surrounding our lead asset, which is the treatment for bladder cancer.
TMH: What are some of the upcoming milestones for Theralase?
DuMoulin-White: Well, the company’s working on FDA breakthrough designation approval. We met with the FDA in July. We’re working on some of their recommendations. We hope to complete that in the first quarter of 2024. In addition, we’re also looking to complete the enrollment of our clinical study for the remaining 37 patients by the end of December 2024.
If the company’s able to complete this task and get all the patients enrolled and provided the primary study treatment, we should have a complete dataset by mid 2026, which we’ll be able to submit to FDA and Health Canada for formal approval and commercialization.
TMH: From a broader outlook, what would you tell investors interested in adding a clinical-stage pharmaceutical company to their portfolio?
DuMoulin-White: Ryan, that’s a good question. I believe investing in clinical stage pharmaceutical companies has a lot of merit. The rewards are very high but so are the risks. Therefore, I would recommend to a potential investor that is looking to get into this space to do their own due diligence to ensure that the technology behind the company is valid.
If they’re not rocket scientists, they don’t fully understand the very complex technology, that’s fine. Just look for organizations that the company works with and if they work with some of the top teaching hospitals in the world like Theralase does, chances are pretty strong that the technology is for real.
The other thing I would recommend is that they take a position they’re comfortable investing and holding. It’s not an industry where you can flip in and flip out of the stock. These investments take time, years, if not decades to come to fruition but if an investor is patient and the technology is successful, their rewards can be life-changing.
You can find Theralase Technologies Inc. on the TSX Venture Exchange under the symbol V.TLT or head to its website at theralase.com for more information.
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